의료기관 조제실제제의 안전한 관리방안 마련을 위한 연구

A Comparative Study on the Safe Management of Compounding Preparations in the Hospital Setting

Compounding preparations are medications that are prepared in the hospital setting when they are needed for patient care but not marketed by manufacturing or importing companies. This study was performed to investigate current proposals and actual productions of compounding preparations and management practices in hospital pharmacies nationwide, and to make suggestions for a comprehensive and effective management system by comparing and analyzing the national and foreign safety management systems. As a result of this study, we figured out 1,984 compounding preparations in the hospital setting were proposed, and 1,181 of them (59.5%) were actually produced in 2014. The majority of the preparations were reported from metropolitan areas including Seoul and Gyeonggi-do since there are many major medical centers and hospitals in this area. Majority of the compounded medications were solutions for external use, particularly antiseptic solutions. The study showed variety of status of approval procedure, regular report, information for beyond use date and managing pharmacist education in survey hospitals. Compared to other foreign countries, the range of the compounding in Korea has been limited to prescription drugs excluding narcotics, psychotropic drugs and nonprescription medications. Compounding preparations will be able to deal with the situations in which patients are not satisfied with the marketed medications and need individualized medications regimen. It is necessary to standardize safe management for production and using of compounding preparations.